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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042858
Receipt No. R000048910
Scientific Title The frequency of postoperative BNP measurement and intervention threshold of BNP concentration in pediatric cardiac intensive care unit: Multicenter study in Japan
Date of disclosure of the study information 2020/12/26
Last modified on 2020/12/26

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Basic information
Public title The frequency of postoperative BNP measurement and intervention threshold of BNP concentration in pediatric cardiac intensive care unit: Multicenter study in Japan
Acronym Post operative BNP study for CHD children in Japan
Scientific Title The frequency of postoperative BNP measurement and intervention threshold of BNP concentration in pediatric cardiac intensive care unit: Multicenter study in Japan
Scientific Title:Acronym Post operative BNP study for CHD children in Japan
Region
Japan

Condition
Condition congenital heart disease
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate therapeutic intervention threshold of BNP concentration in pediatric cardiac intensive care unit
Basic objectives2 Others
Basic objectives -Others how did the Japanese pediatric cardiac intensivists measure BNP in PCICU
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the threshold of BNP values for any therapeutic interventions
Key secondary outcomes how did the Japanese pediatric cardiac intensivists measure BNP in PCICU

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria We included all patients under 15 years of age who underwent pediatric cardiac surgery with or without cardiopulmonary bypass (CPB) during the period
Key exclusion criteria We excluded those who could not later be analyzed due to missing data
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Tomoyuki
Middle name
Last name Kanazawa
Organization Okayama University Hospital
Division name Anesthesiology and Resuscitology
Zip code 7008558
Address 2-5-1, Shikata-cho, Kita-ku
TEL 0862357778
Email tyskanazawa@gmail.com

Public contact
Name of contact person
1st name Tomoyuki
Middle name
Last name Kanazawa
Organization Okayama University Hospital
Division name Anesthesiology and Resuscitology
Zip code 7008558
Address 2-5-1, Shikata-cho, Kita-ku
TEL 0862357778
Homepage URL
Email tyskanazawa@gmail.com

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Okayama University Hospital Institutional Review Board
Address 2-5-1 Shikatachou, Kitaku, Okayama, Okayama 700-8525, Japan
Tel 0862356503
Email mae6605@adm.okayama-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 12 Month 26 Day

Related information
URL releasing protocol http://www.okadaimasui.com/jp/clinicalstudy/index.html
Publication of results Unpublished

Result
URL related to results and publications http://www.okadaimasui.com/jp/clinicalstudy/index.html
Number of participants that the trial has enrolled 108
Results A total of 246 BNP measurements for 108 patients were included. 39 measurements were used as a criterion to decide to intervene children. The number of BNP measurements in each group is as follows: group A 113, group B 81, group C 45, group D 7. The intervention ratio in each group was 6.2% (group A), 8.6% (group B), 44.4% (group C), and 71.4% (group D). The intervention ratio of group C and D were significantly higher than group A: (Odds ratio (95%CI): 12.1(4.8-33.9), p<0.0001, 25.2(5.2-146.2), p<0.0001).
Results date posted
2020 Year 12 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics The median age of the patients was 5 (1,17.5: interquartile range, IQR) months and the median weight was 4.6 (3.2,8.4: IQR) kg. Of all patients, 58.2% were male.
Participant flow After admission to the pediatric cardiac intensive care unit, all BNPs enrolled in the study and measured during admission were prospectively extracted.
Adverse events none
Outcome measures BNP measurement
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 05 Month 14 Day
Date of IRB
2015 Year 07 Month 28 Day
Anticipated trial start date
2015 Year 08 Month 21 Day
Last follow-up date
2016 Year 07 Month 31 Day
Date of closure to data entry
2016 Year 10 Month 31 Day
Date trial data considered complete
2020 Year 10 Month 17 Day
Date analysis concluded
2020 Year 12 Month 20 Day

Other
Other related information none

Management information
Registered date
2020 Year 12 Month 26 Day
Last modified on
2020 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048910

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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